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To begin using your site, click Create a Post under Blog Tools.
What is a Blog?
A Blog is a Web site designed to help you share information related to a particular subject area in the form of text, images, links, and other media such as video. Blogs can be used as team sites, news sites, journals, diaries, and more.
Blog posts usually consist of frequent short postings and are typically displayed in reverse chronological order (newest entries first). Blogs encourage site visitors to interact with one another by leaving comments on posts.
Blogs can be also be used as a team communication tool. Keep team members informed by providing a central place for links and relevant news. Thanks for the new account - what is next? Driven by both the need to meet FDA and genuine desires to drive improved quality, quality management systems encompassing SOP, Corrective and Preventative Actions (CAPA) and related processes have existed for many years, both in paper and electronic form. The impact of quality management systems on “actual” quality, however, is often reported as far less than desired.  Quality management software systems that include two key features – a true closed loop design and support for collaborative processes in parallel with the formal forms-driven processes – have the potential to close the gap between simply accomplishing regulatory compliance and delivering measurable improvements in quality.
In August 2002, the Food and Drug Administration (FDA, or “the Agency”) announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century, to enhance and modernize the regulation of pharmaceutical manufacturing and product quality. The agency codified its approach in the report “Pharmaceutical Quality for the 21st Century: A Risk-Based Approach.” Subsequently, the Agency has made significant progress in implementing the concepts of "Quality by Design" (QbD) into its processes.
Working with regulators in the European Union (the European Medicines Agency) and Japan, FDA has promoted Quality by Design objectives through the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH guidelines Q8 (on Pharmaceutical Development) [1], Q9 (on Quality Risk Management) [2], and Q10 (on Pharmaceutical Quality System) [3] provide guidance for manufacturers implementing Quality by Design.
Incorporating Quality by Design concepts and moving to a risk-based approach have clearly driven the adoption of both paper-based and software-based quality systems. The actual impact on product quality, however, is less clear.
Quality by design means designing and developing a product and associated manufacturing processes that will be used during product development to ensure that the product consistently attains a predefined quality at the end of the manufacturing process. Going to use some formatting....
To succeed in Tier 2 and 3, our product needs to:
- Improve the user experience. Because regulatory systems manage a large number of documents across many products and studies, and need a rich taxonomy, locating a document or a set of documents must be simple. The system must support working with documents individually and in sets. These sets may be permanent – such as the components of a clinical study report – or ad hoc, such as a group of related drug substance documents. The system must provide the user with user-friendly automation and options around to handle workflow and lifecycle of individual documents and sets of documents.
- Address 95% of common use cases for that market. Many clients (especially larger clients) can defined edge cases that they feel are important. However, a core set of processes can be identified
To succeed in Tier 2 and 3, our product needs to:
- Improve the user experience. Because regulatory systems manage a large number of documents across many products and studies, and need a rich taxonomy, locating a document or a set of documents must be simple. The system must support working with documents individually and in sets. These sets may be permanent – such as the components of a clinical study report – or ad hoc, such as a group of related drug substance documents. The system must provide the user with user-friendly automation and options around to handle workflow and lifecycle of individual documents and sets of documents.
Address 95% of common use cases for that market. Many clients (especially larger clients) can defined edge cases that they feel are important. However, a core set of processes can be identified To succeed in Tier 2 and 3, our product needs to:
- Improve the user experience. Because regulatory systems manage a large number of documents across many products and studies, and need a rich taxonomy, locating a document or a set of documents must be simple. The system must support working with documents individually and in sets. These sets may be permanent – such as the components of a clinical study report – or ad hoc, such as a group of related drug substance documents. The system must provide the user with user-friendly automation and options around to handle workflow and lifecycle of individual documents and sets of documents.
Address 95% of common use cases for that market. Many clients (especially larger clients) can defined edge cases that they feel are important. However, a core set of processes can be identified
To succeed in Tier 2 and 3, our product needs to:
- Improve the user experience. Because regulatory systems manage a large number of documents across many products and studies, and need a rich taxonomy, locating a document or a set of documents must be simple. The system must support working with documents individually and in sets. These sets may be permanent – such as the components of a clinical study report – or ad hoc, such as a group of related drug substance documents. The system must provide the user with user-friendly automation and options around to handle workflow and lifecycle of individual documents and sets of documents.
Address 95% of common use cases for that market. Many clients (especially larger clients) can defined edge cases that they feel are important. However, a core set of processes can be identified Blogging can be one of the most influential practices an organization can adopt to improve visibility and build a community. As a platform, it promotes quality, visibility, engagement, and accountability. By using a blog effectively, we can increase our visibility with stakeholders, and the general public to increase our presence in the market and build new opportunities.
Below are some Blogging best practices we should consider using, and standardizing upon. - Great Blogs are Interactive - Great blogs not only provide content to users but also build social networks with their readers and other bloggers. The ability to add comments, share on social networking sites, integrate with mobile devices, and other forms of user interaction are crucial to keeping the site dynamic and engaging.
- Embrace Mobile Devices - When do readers have the most time to read blog posts? On their own time. By using RSS feeds, mobile device views, apps, and shared platforms we give users the ability to follow our blog through aggregators or access content on the go.
- Quality Images Drive Traffic - Great imagery that have a similar level of look/feel/stylization help keep a blog site engaging and enhance the visual impact of the overall site.
- There are great rights-free photo sources such as SXC.HU that are very helpful
- Short is Sweet - Capture interest and then allow users to dive deeper into their interests.
- Many successful blogs will have a singular first paragraph to provide a summary for the post and garner interest (usually accompanied by some form of imagery). Users can click a "Read more" button or the Blog Title/Image to access the full posting.
- This reduces the fatigue on users moving through the site and allows more blog postings to fit on a single page.
- Keyword and Hyperlink Optimization - The use of keywords helps increase blog visibility in search engines, but the most important impact can be found in the placement of Hyperlinks that reach outside your domain. Establishing collaborative relationships with other blogs or websites (including press releases which are replicated 10 fold) can dramtically increase the visibility of the blog.
- A Great Example: For format, visibility, and functionality, this is one of the best: Gizmodo
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